FDA Registration
Active
🇩🇪 Germany
ULRICH GMBH & CO. KG
Reg #: 9612420
·
FEI: 3002807156
·
Expires 2026
Products
36
Proprietary Names
45
Establishment Types
3
Classifications
36
Registration Details
- Registration Name
- ULRICH GMBH & CO. KG
- Registration Number
- 9612420
- FEI Number
- 3002807156
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- BUCHBRUNNENWEG 12
- City
- ULM Baden-Wurttemberg
- Country
- DE
Regulatory Submissions
- 510(k) Number
- K150408
Owner / Operator
- Firm Name
- ULRICH GMBH & CO. KG
- Operator Number
- 8010776
- Address
- BUCHBRUNNENWEG 12, --
- City
- ULM
- State
- Baden-Wurttemberg
- Postal Code
- D-89081
- Country
- DE
US Agent
- Business Name
- ULRICH MEDICAL USA, INC.
- Contact Name
- Eric Gibbs
- Address
- 3700 East Plano Parkway, Suite 200
- City
- Plano
- State
- TX
- ZIP
- 75074
- Country
- US
- [email protected]
- Phone
- 469 2380832 ext. 106
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Bone Cement | LOD | Class 2 | Orthopedic | No | 2021-12-10 |
| Cement, Bone, Vertebroplasty | NDN | Class 2 | Orthopedic | No | 2021-12-10 |
| Gauge, Depth | HTJ | Class 1 | Orthopedic | No | 1994-08-10 |
| Awl | HWJ | Class 1 | Orthopedic | No | 1994-08-10 |
| Spinal Vertebral Body Replacement Device | MQP | Class 2 | Orthopedic | No | 2007-12-04 |
| Chisel, Surgical, Manual | FZO | Class 1 | General, Plastic Surgery | No | 1994-08-10 |
| Appliance, Fixation, Spinal Interlaminal | KWP | Class 2 | Orthopedic | No | 2015-10-05 |
| Posterior Cervical Screw System | NKG | Class 2 | Orthopedic | No | 2015-10-05 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | Class 2 | Orthopedic | No | 2013-06-27 |
| Reamer | HTO | Class 1 | Orthopedic | No | 2011-04-28 |
| Rongeur | HTX | Class 1 | Orthopedic | No | 1994-08-10 |
| Tray, Surgical | LRP | Class 1 | General, Plastic Surgery | No | 2004-03-23 |
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | Class 2 | Orthopedic | No | 2024-04-30 |
| Injector, Contrast Medium, Automatic | IZQ | Class 2 | Cardiovascular | No | 2020-08-04 |
| Trocar, Ent | KTE | Class 1 | Ear, Nose, Throat | No | 2004-03-23 |
| Impactor | HWA | Class 1 | Orthopedic | No | 1994-08-10 |
| Hook, Surgical, General & Plastic Surgery | GDG | Class 1 | General, Plastic Surgery | No | 2004-03-23 |
| Pusher, Socket | HXO | Class 1 | Orthopedic | No | 2013-05-10 |
| Thoracolumbosacral Pedicle Screw System | NKB | Class 2 | Orthopedic | No | 2019-10-16 |
| Twister, Wire | HXS | Class 1 | Orthopedic | No | 1994-08-10 |
| Retractor | GAD | Class 1 | General, Plastic Surgery | No | 1994-08-10 |
| Orthopedic Manual Surgical Instrument | LXH | Class 1 | Orthopedic | No | 1994-08-10 |
| Curette, Surgical, General Use | FZS | Class 1 | General, Plastic Surgery | No | 1994-08-10 |
| Spinal Vertebral Body Replacement Device - Cervical | PLR | Class 2 | Orthopedic | No | 2022-03-18 |
| Holder, Needle; Orthopedic | HXK | Class 1 | Orthopedic | No | 2009-04-08 |
| Guide, Surgical, Instrument | FZX | Class 1 | General, Plastic Surgery | No | 2004-03-23 |
| Bit, Drill | HTW | Class 1 | Orthopedic | No | 2004-03-23 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | Class 1 | General, Plastic Surgery | No | 2004-03-23 |
| Orthosis, Spinal Pedicle Fixation | MNI | Class 2 | Orthopedic | No | 2013-03-06 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | Class 2 | Orthopedic | No | 2013-03-06 |
| Probe | HXB | Class 1 | Orthopedic | No | 1994-08-10 |
| Tray, Surgical, Instrument | FSM | Class 1 | General, Plastic Surgery | No | 1994-08-10 |
| Forceps | HTD | Class 1 | General, Plastic Surgery | No | 1994-12-29 |
| Orthopedic Stereotaxic Instrument | OLO | Class 2 | Neurology | No | 2020-11-12 |
| Screwdriver | HXX | Class 1 | Orthopedic | No | 1994-04-01 |
| Gouge, Surgical, General & Plastic Surgery | GDH | Class 1 | General, Plastic Surgery | No | 2012-12-06 |
Proprietary Names
V-STEADY
ULRICH DEPTH GAUGE
ULRICH AWL
obelisc
ULRICH CHISEL
neon3
tezo Titanium Cage Family
ULRICH REAMER
ULRICH
ZIELKE RONGEUR
ULRICH TRAY
uNion® MAX Cervical Plate System
ulrichINJECT CT motion
ULRICH TROCAR
Cortium
AddPlus, Anterior Distraction Dev.
small VBR
HARMS IMPACTOR
ULRICH IMPACTOR
ULRICH HOOK
Pusher, Socket
Momentum Posterior Spinal Fixation System
ULRICH JET TWISTER
ULRICH SPREADER
ULRICH INSTRUMENTS
ULRICH CURETTE
ulricheasyINJECT Max
Small VBR
pezo PEEK cage family
ULRICH NEEDLEHOLDER
ULRICH GUIDE
ULRICH BIT, DRILL
ULRICH CLAMP
uCentum
ULRICH USIS PROBE
Momentum® MIS Posterior Spinal Fixation System
ULRICH INSTRUMENT TRAY
IMPLANT TRAY
ULRICH FORCEPS
Solidity Vertebral Body Replacement
Navigation Module of the Momentum System
mambo
uNion
ULRICH SCREWDRIVER
Gouge
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)